BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER Q

    MDR report key: 8954439 · Received September 3, 2019

    Report

    Report Number
    3002806902-2019-00003
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 6, 2019
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    GEX
    PMA / PMN Number
    K992824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS SOON AS ELLEX MEDICAL WAS NOTIFIED OF THE EVENT , THE DEVICE WAS QUARANTINED UNTIL THE SYSTEM WAS INSPECTED BY THE ELLEX SERVICE TECHNICIAN AND THE FAULTY JOYSTICK WAS SWAPPED WITH A NEW ONE. THE SERVICE TECHNICAIN FOUND THE JOYSTICK WIRE WAS DAMAGED. THE FAULTY JOYSTICK WAS SENT TO THE ELLEX MEDICAL (HEAD OFFFICE), IN ADELAIDE WHERE THE INVESTIGATION REVEALED THE BELOW : THE DEVICE LEFT THE FACTORY IN (B)(6)2007 WITH A TEFLON JOYSTICK FOOT FITTED IN.IT WAS THEN RECALLED AS PART OF GLOBAL SERVICE BULLETIN -07-08.3 (ATTACHED) TO ADD THE RETAINING CLIP IN THE FIELD, BUT APPARENTLY THE MODIFICATION WAS NOT CARRIED OUT FOR THIS UNIT, AS WAS EVIDENT FROM THE EVALUATION OF THE RETURNED JOYSTICK. THE REPORTED "MISFIRING" MUST HAVE OCCURRED WHEN THE DAMAGED WIRE MADE CONTACT WITH THE EARTHED JOYSTICK CHASSIS IN READY MODE. THE COMMUNICATION WITH THE FDA DATED (B)(6)2018 (ATTACHED) HAS NOT INDICATED ANY CONCERNS OF THE EFFECTIVENESS OF THE RECALL AND THIS IS AN ISOLATED INCIDENT RESULTING PROBABLY FROM A NON-RESPONSIVE CUSTOMER. AS PER THE RECALL STRATEGY DETAILED TO THE FDA THE FIELD CORRECTION 07/08.3 WAS TO BE CONDUCTED AT THE NEXT SERVICE CALL FOR EACH IDENTIFIED SYSTEM. IT IS ASSUMED THAT THE CUSTOMER DID NOT ARRANGE THE PREVENTIVE MAINTENANCE AS THEY SHOULD HAVE, WHICH EXPLAINS THE REASON FOR THE MISSING RETAINING CLIP FROM THIS UNIT. AS MENTIONED , THERE WAS NO INJURY REPORTED AS THE DEVICE WENT TO STANDBY AFTER THE REPORTED MISFIRING. HOWEVER THERE COULD HAVE BEEN A POTENTIAL FOR HARM, HENCE ELLEX CONSIDERS IT OBLIGATORY TO REPORT THE INCIDENT. THE REPORT WAS SENT ON (B)(6)2019 AND NOT ON (B)(6) ( AS MENTIONED IN THE RESUBMISSION OF HTE INITIAL REPORT). THE DELAY WAS CAUSED DUE TO AN ISSUE ENCOUNTERED IN THE ESG PROCESS.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT . THE DEFECT WAS OBSERVED IN USA ON AN ELLEX LASER SYSTEM 'SUPER Q' SUPPLIED IN (B)(6)2007. CUSTOMER CALLED TO REPORT THAT THEIR SYSTEM FIRED 2-3 SHOTS ON ITS OWN DURING A CAPSULOTOMY WITHOUT THE DOCTOR PRESSING THE TRIGGER. ALSO, THE SYSTEM RANDOMLY WENT INTO STANDBY. NO PATIENT INJURY WAS REPORTED AS A RESULT.

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX MEDICAL WAS NOTIFIED OF THE EVENT , THE DEVICE WAS QUARANTINED UNTIL THE SYSTEM WAS INSPECTED BY THE ELLEX SERVICE TECHNICIAN AND THE FAULTY JOYSTICK WAS SWAPPED WITH A NEW ONE. THE SERVICE TECHNICIAN FOUND THE JOYSTICK WIRE WAS DAMAGED. THE FAULTY JOYSTICK WAS SENT TO THE ELLEX MEDICAL (HEAD OFFICE), IN (B)(6) WHERE THE INVESTIGATION REVEALED THE BELOW: THE DEVICE LEFT THE FACTORY IN JUL 2007 WITH A TEFLON JOYSTICK FOOT FITTED IN IT WAS THEN RECALLED AS PART OF GLOBAL SERVICE BULLETIN (B)(4) TO ADD THE RETAINING CLIP IN THE FIELD, BUT APPARENTLY THE MODIFICATION WAS NOT CARRIED OUT FOR THIS UNIT, AS WAS EVIDENT FROM THE EVALUATION OF THE RETURNED JOYSTICK. THE REPORTED "MISFIRING" MUST HAVE OCCURRED WHEN THE DAMAGED WIRE MADE CONTACT WITH THE EARTHED JOYSTICK CHASSIS IN READY MODE. THE COMMUNICATION WITH THE FDA DATED 5TH JULY 2018 HAS NOT INDICATED ANY CONCERNS OF THE EFFECTIVENESS OF THE RECALL AND THIS IS AN ISOLATED INCIDENT RESULTING PROBABLY FROM A NON-RESPONSIVE CUSTOMER. AS PER THE RECALL STRATEGY DETAILED TO THE FDA THE FIELD CORRECTION (B)(4) WAS TO BE CONDUCTED AT THE NEXT SERVICE CALL FOR EACH IDENTIFIED SYSTEM. IT IS ASSUMED THAT THE CUSTOMER DID NOT ARRANGE THE PREVENTIVE MAINTENANCE AS THEY SHOULD HAVE, WHICH EXPLAINS THE REASON FOR THE MISSING RETAINING CLIP FROM THIS UNIT. AS MENTIONED, THERE WAS NO INJURY REPORTED AS THE DEVICE WENT TO STANDBY AFTER THE REPORTED MISFIRING. HOWEVER THERE COULD HAVE BEEN A POTENTIAL FOR HARM, HENCE ELLEX CONSIDERS IT OBLIGATORY TO REPORT THE INCIDENT. THIS REPORT WAS SENT ON 3RD JULY BUT THERE WAS AN ISSUE ENCOUNTERED IN THE ESG PROCESS.

    Description of Event or Problem · 1

    THE DEFECT WAS OBSERVED IN USA ON AN ELLEX LASER SYSTEM 'SUPER Q' SUPPLIED IN JULY 2007. CUSTOMER CALLED TO REPORT THAT THEIR SYSTEM FIRED 2-3 SHOTS ON ITS OWN DURING A CAPSULOTOMY WITHOUT THE DOCTOR PRESSING THE TRIGGER. ALSO, THE SYSTEM RANDOMLY WENT INTO STANDBY. NO PATIENT INJURY WAS REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748011 SUPER Q OPHTHALMIC LASER GEX ELLEX MEDICAL PTY LTD LQP3106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other